Bachelor s or master s degree in Computer Science, Technical Communication, English, Life Sciences, or a related Engineering field (eg, Biomedical)
Working knowledge of key regulations, including FDA 21 CFR Part 820/Part 11, ISO 14971 (Risk Management), and GAMP 5, with the ability to maintain strict adherence to corporate style guides
Experience in a regulated setting such as a medical domain, is a plus
2+ years of professional technical writing experience in a software or hardware environment
Strong experience in Adobe InDesign, Adobe Photoshop, Adobe Illustrator, and Camtasia for video creation
Mastery of professional authoring tools (eg, Vasont, MadCap Flare, FrameMaker) and a strong working knowledge of document management and version control systems
Excellent interpersonal and writing skills, with self-motivation to quickly learn new molecular diagnostic technologies, such as PCR and clinical lab workflows
Familiarity with medical regulations (FDA, ISO, GAMP) and molecular diagnostic technologies is a significant advantage
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